In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Caltrate Drug Master File in Korea (Caltrate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Caltrate. The MFDS reviews the Caltrate KDMF as part of the drug registration process and uses the information provided in the Caltrate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Caltrate KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Caltrate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Caltrate suppliers with KDMF on PharmaCompass.